Cardiac Magnetic Resonance Monitoring of Immune Checkpoint Inhibitor-related Cardiotoxicity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-23

Study Completion Date

2027-12-31

Brief Summary

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This study is a prospective cohort clinical research that analyzes the changes in CMR parameters before and after immune checkpoint inhibitors (ICIs) therapy in patients with gynecologic malignancies. It also evaluates the value of CMR parameters in predicting long-term outcomes. The baseline assessment will be conducted prior to ICIs treatment, followed by multiple assessments during the medication process including within one week prior to cycle 3 , within the week prior to cycle 5 , 1 year after the first dose, and 2 years after the first dose. Assessment will also be conducted after discontinuation of ICIs medication. The assessment includes clinical assessment, CMR imaging, echocardiography, serum cardiac injury biomarkers, etc. Cancer therapy-related cardiac dysfunction (CTRCD), survival, and major adverse cardiac events (MACE) will be followed up.

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Detailed Description

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Conditions

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Immune Checkpoint Inhibitors, Cardiotoxicity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with gynecologic malignancies who are preparing for ICIs treatment

Cardiac magnetic resonance

Intervention Type DIAGNOSTIC_TEST

Cardiac magnetic resonance protocols include cine, non-contrast T1-mapping and T2-mapping.

Interventions

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Cardiac magnetic resonance

Cardiac magnetic resonance protocols include cine, non-contrast T1-mapping and T2-mapping.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 1\. Female patients aged 18 to 75 years, diagnosed with gynecological malignancies through histology or cytology.
* 2\. Patients who are preparing for monotherapy or combination therapy with ICIs.
* 3\. Voluntary signing of informed consent form.
* 4\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* 5\. Expected survival of at least 6 months.

Exclusion Criteria

* 1\. Previously received ICIs treatment.
* 2\. With allergies or contraindications to ICIs.
* 3\. Confirmed to be brain metastasis.
* 4\. Patients who have major surgery within 4 weeks prior to or following the screening period.
* 5\. Patients who have received systemic corticosteroids (at a dose equivalent to \>10 mg prednisone per day) or other immunosuppressive medications within 14 days prior to enrollment or during the study period; however, the following situations are allowed for inclusion:

1. the use of topical or inhaled corticosteroids is permitted;
2. short-term (≤7 days) use of corticosteroids for prevention or treatment of non-autoimmune diseases is allowed.
* 6\. Left ventricular ejection fraction (LVEF) ≤50%, or New York Heart Association functional classification (NYHA) ≥III.
* 7\. Coronary heart disease, cardiomyopathy, congenital heart disease, valvular heart disease and pericardial diseases with confirmed diagnosis.
* 8\. Lack of autonomous capacity, or a documented history of mental disease.
* 9\. MRI contraindications: Pacemakers, neurostimulators, artificial metal heart valves, arterial aneurysm clips, intraocular metallic foreign bodies, inner ear implants, metal prostheses, metal limbs, metal joints, and any other metallic implants or foreign objects; severe hyperthermia patients; claustrophobia; severe respiratory conditions that prevent breath-holding.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No